A Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Function at Vary… (NCT07388043) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Function at Varying Dosages in Healthy Middle-aged and Older Adults With Self-reported Memory Problems
Canada120 participantsStarted 2026-05
Plain-language summary
The goal of this clinical trial is to safety and efficacy of AP-Brain on cognitive function at varying dosages in healthy middle-aged and older adults with self-reported memory problems. The main question it aims to answer is:
What is the effect of AP-Brain at 1 g, 3 g, and 5 g on cognitive function?
Participants will be asked to consume AP-Brain at 1 g, 3 g, or 5g, or Placebo and asked to complete memory assessment questionnaires.
Who can participate
Age range40 Years – 79 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males and females 40-79 years of age, inclusive
✓. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
✓. Individuals with self-reported memory problems as assessed by a combined score of ≥6 from the memory assessment questions provided at screening
✓. Absence of dementia or other significant cognitive impairment as assessed by MMSE-2 score of ≥24 at screening
✓. Agrees to avoid high sources of caffeine (e.g., supplements, tea, coffee, energy drinks), NSAIDs, and alcohol consumption for 24 hours prior to post-screening clinic visits
✓. Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screening clinic visits
✓. Agrees to avoid moderate-vigorous exercise 12 hours prior to post-screening clinic visits
✓. Agrees to avoid travel across two or more time zones two weeks prior to any study visit
Exclusion criteria
✕. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
✕. Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
✕
What they're measuring
1
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by the CNS VS Neurocognitive Index (NCI) score
Timeframe: Day 0 to 56
2
Change from baseline to Day 56 between AP-Brain and placebo in cognitive function, as assessed by complex attention via the CNS VS battery test
. Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., attention-deficit/hyperactivity disorder, Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, neurodegenerative disease, infections, insomnia, depression, epileptic or other seizure-related disorders) that could interfere with study participation as assessed by the QI
✕. Self-reported color blindness/weakness as assessed by the QI
✕. Individuals who consume high caffeine daily or are addicted to caffeine at screening as assessed by the QI
✕. Current employment that calls for overnight shiftwork as assessed by the QI
✕. Unstable metabolic disease or chronic diseases as assessed by the QI
✕. Current or history of significant diseases of the gastrointestinal tract or conditions that result in malabsorption, as assessed by the QI